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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th May 1993 to 18th May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 4421 to 5333 grams
- Housing: Individual suspended mesh bottom cages
- Diet:ad libitum
- Water: tap water ad libitum
- Acclimation period: a minimum of 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 42-76 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: Back
- Type of wrap if used: Each sample was applied under a 2.5 cm² gauze patch that was overwrapped with a gauze binder and secured with tape. Plastic restraint collars were applied and remained on the animals for the duration of exposure.
REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the test site was wiped with paper towels moistened with mineral oil (USP).
OBSERVATION TIME POINTS
The rabbits were observed at 1, 24, 48 and 72 hours after partch removal and daily thereafter through day 14 if irritation persisted.
SCORING SYSTEM:
- Method of calculation: Draize
Erythema and Eschar Formation
No erythema – 0
Very slight erythema (barely perceptible, edges of area not well defined) – 1
Slight erythema (pale red in colour) – 2
Moderate to severe erythema (definite red in colour and area well defined) – 3
Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth) – 4
Oedema formation
No Oedema – 0
Very slight oedema (barely perceptible, edges of area not well defined) – 1
Slight oedema (edges of area well defined by definite raising) – 2
Moderate oedema (raised approximately 1 mm) – 3
Severe oedema (raised more than 1 mm and sever oedema extending beyond area of exposure) - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material induced slight to moderate erythema on all rabbits and very slight to slight oedeman in four rabbits. Desquamation was presented on all sites by day 7. All oedema completely subsided by day 9 or earlier. Minor reversible (grade 1) erythema on one site and desquamation on four sites persisted through study termination.
- Other effects:
- There were no unscheduled deaths during the course of the study.
There were no significant effects on body weight changes during the study (animals were weighed on day 0 and at study termination).
Any other information on results incl. tables
Table 1: Results
Animal |
Observation |
1 hour |
24 hours |
48 hours |
72 hours |
4 days |
5 days |
6 days |
7 days |
8 days |
9 days |
10 days |
11 days |
12 days |
13 days |
14 days |
1 |
Erythema |
2 |
3 |
3 |
3 |
3 |
3d |
2d |
2d |
1d |
1d |
1d |
1d |
1d |
1d |
1d |
Oedema |
0 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
2 |
2 |
2 |
2 |
2d |
2d |
2d |
1d |
1d |
1d |
0d |
0d |
0d |
0 |
- |
Oedema |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
3 |
Erythema |
2 |
3 |
3 |
3 |
3 |
3d |
2d |
2d |
2d |
1d |
1d |
1d |
0d |
0d |
0d |
Oedema |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Erythema |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1d |
1d |
1d |
1d |
0d |
0d |
0d |
0d |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
Erythema |
2 |
3 |
2 |
3 |
3d |
3d |
3d |
2d |
2d |
1d |
1d |
1d |
0d |
0d |
0d |
Oedema |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
Erythema |
2 |
2 |
2 |
2 |
2 |
2d |
1d |
1d |
1d |
1d |
1d |
1d |
0d |
0 |
- |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
d = desquamation |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material induced slight to moderate erythema on all rabbits. Four sites had very slight to slight oedema. Desquamation was present on all sites by the end of the first week of the study. In general erythema and oedema had completely subsided by day 12 or earlier with the exception of one animal where very slight erythema persisted to day 14. Four animals had desquamation at study termination. The primary irritation index was calculated as 2.8 which equates to the description of moderately irritating, however in accordance with the criteria outlined in Regulation EC 1272/2008 (CLP), the test material is not classified.
- Executive summary:
The skin irritation of the test material was investigated in female albino rabbits in accordance with OECD 404, EU Method B.4 and EPA OTS 798.4470. The test material induced slight to moderate erythema on all rabbits. Four sites had very slight to slight oedema. Desquamation was present on all sites by the end of the first week of the study. In general erythema and oedema had completely subsided by day 12 or earlier with the exception of one animal where very slight erythema persisted to day 14. Four animals had desquamation at study termination. The primary irritation index was calculated as 2.8 which equates to the description of moderately irritating, however in accordance with the criteria outlined in Regulation EC 1272/2008 (CLP), the test material is not classified (the test material induced a positive response in 3/6 animals).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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